Medical Device Accidents And User Errors

Safe Use Of Medical Equipment

medical device accidents and user errors are problems that must not be ignored and need to focus on because accidents occurred in the health sector cause patient death, or at least cause an injury and disability.

 According to the Food and Drug Administration (FDA), in the United States, about 1,3 million people are injured each year by accidents caused from medical devices. The FDA receives more than 95.000 medical device accident reports annually (. In 2002 alone, FDA declared that medical device accidents of more than 111.000 causing serious injuries and deaths. In a study performed by Harvard Medical Practice Study, it was explained that 70% of 30.000 medical device injuries are caused by medical device accidents while 27,6% of them are caused by pure negligence. Because the used devices are high-tech, accidents occur largely as a result of user error. Many statistical studies show that user errors are not less. The user errors can be classified in related to hardware design, software design, components and alarms of devices. The errors related to hardware include control/display arrangement errors. Software-related design errors generally result from an unfamiliar language, symbols, codes and functions hidden from the user. For example, in some cardiac output monitor alarm may be disabled without the operator’s knowledge when the control buttons are pushed in a specific sequence. The most common errors reported to FDA are improper installations of device accessories. Some commonly reported errors are tubing connected to the wrong port, loose connections and accidental disconnections. According to Medical Device Recall Reports, several injuries and deaths occurred because of the disconnections of the breathing tubes in the ventilators due to poor tube and connector design.

Equipment can contribute to adverse events either by directly causing the incident or by increasing the likelihood of human errors. Even when equipment malfunction is the direct cause of the accident, malfunctions often can be traced back to human factors. For example, described below is an equipment-related event that occurred in 1998 in the operating room of a hospital in Southwest USA. While the apparent cause of the incident was faulty equipment.

A flash fire broke out during a craniotomy procedure for evacuation of bilateral subdural hematomas. After one hematoma was removed and the neurosurgeon was making an incision to remove the second, a fire broke out on the operating table. The fire destroyed the patient’s oxygen mask and seriously burned his face, ears, neck, and shoulder. It is believed the electrocautery device being used to stop bleeding at the incision sparked the fire.

Most Common Causes of Medical Device Errors

Most medical device errors can be classified into two main categories: operator failures and device failures.

• Operator failures happen when a medical professional misuses the device and this misuse harms the patient
• Device failures happen when a defect in the device itself causes harm despite proper use of the device

There are various operator failures that can happen at various stages of patient treatment, Operator failures can range from choosing the wrong medical device for a patient to failing to use the device correctly.

Failing to use the device correctly could mean different things like.

• Setting the controls incorrectly
• Not setting up the device the right way
• Failing to do any pre-use checks
• Monitoring the device during use to prevent misuse or other errors

Something as seemingly simple as not having enough training to use a medical device could also lead to patient harm.

Device failures range from problems with the design to random component failures.

The causes of medical device accidents fall into four categories:

1. basic device failures( design/labeling error, manufacturing error, random component failure, and invalid device foundation)
2. external factors( electrical power supplies; medical gas and vacuum supplies; electromagnetic or radio frequency interference; and environmental controls)
3. system errors(poor incident/recall reporting systems; failure to impound; lack of competent accident investigation; failure to train and credential; poor pre-purchase evaluation; use of inappropriate devices; and failure to conduct incoming and pre-use inspections)
4. operator errors(device misassembly; inappropriate reliance on an automated feature; accidental misconnections; improper maintenance, testing, repair, or incoming inspection; incorrect clinical use; incorrect control settings; and incorrect programming). The materials department can help to alleviate some of the problem areas through an effective equipment procurement, maintenance, and monitoring program.

ECRI classification of medical device incidents

Preventive And Possible Solutions

Several steps can be taken to eliminate the error-producing factors in the workplace that may cause undesirable equipment-related events. An important issue is communication. Every hospital should have a formal process for identifying product hazards and communicating effective safety practices to all relevant health care professionals. This means that someone, perhaps in the Biomedical Engineering department, should be designated to receive and disseminate information about product recalls and device safety alerts.

• Groups such as the Saudi Food and Drug Administration, the Institute for Safe Medication Practices, and the ECRI and FDA regularly issue equipment hazard reports that are relevant to many different hospital departments. These communications must routinely be distributed to everyone affected by the products in question.

• All material and equipment should be inspected briefly for damage prior to delivery to patient care units. This inspection involves both the packaging and the equipment/device.

Typical steps include the following:

• Conduct a visual through-the-packaging inspection of the equipment/device for obvious defects.
• Check the package integrity. Are the package and seals intact?
• Verify the package label. Does the label accurately identify the equipment/device contained in the package? If the device has an expiration date, has the date passed?
• While inspecting the item, ask yourself these questions:

1. Is there any debris or unidentified material within the package?
2. Is the equipment/device complete and properly assembled?
3. Are there any external defects (e.g., broken insulation of disposable electrodes, cracks or splits in catheters)?
4. Are all connections and junctions intact and secure?

It is necessary to involve the biomedical engineering department in the inspection of All medical equipment pre-use it or shift it to the care area

The Biomedical Engineering department also can help in identifying high-risk equipment/devices. High-risk products are those that require repeated repair or replacement. The information found in the log of items sent out of the hospital for repair or replacement can be used to evaluate whether the repair rate for a piece of equipment/a device is increasing (a signal that the reliability is decreasing) and determine if repair/replacement rates are higher in a particular unit (a signal of possible misuse or lack of staff knowledge). The Biomedical Engineering department staff often are aware of the scope of equipment problems and complaints voiced by physicians and clinical staff. These concerns can be early-warning signs of an impending equipment-related patient incident. If one or more of the situations listed in the list, below,is identified, the Biomedical Engineering department should bring the concerns to the attention of the patient safety or other relevant committee.

How many of these equipment-related early warning signs are present in your environment?

• only a few people seem to be using the equipment.
• People tend to modify equipment and take shortcuts.
• People refuse to use the materials/equipment.
• People complain that installation of accessories is difficult, confusing, or overly time-consuming.
• Alarms and batteries often fail.
• Incorrect accessories are sometimes installed.
• Parts often become detached.
• People complain that equipment displays are difficult to read or understand.
• People complain that equipment controls are poorly located or labeled.
• People say the alarms are difficult to hear or distinguish.
• People find the alarms very annoying.
• People complain that equipment operation is illogical and confusing.

Biomedical engineering is responsible for procuring quality materials, supplies, and equipment use at the lowest total delivered cost. However, these decisions should not be made in isolation from those who use the products. Every patient care device should be evaluated by user groups to determine if the equipment:

• conforms to user expectations
• is easy to learn how to operate
• contains easily perceived displays and simple controls
• provides relevant information to the user, thus avoiding reliance on the user’s memory
• comes with clear and adequately detailed user documentation and technical manuals.

Studies of medical device accidents show that operator error accounts for 50% to 70% of the problems. The goal is to ensure that operators are proficient in critical tasks. Critical tasks are those requiring human performance, which if not accomplished in accordance with product requirements will most likely have adverse effects on equipment reliability or safety.

Before purchasing new patient care supplies, accessories, and equipment, the materials and Biomedical engineering department must make clinical departments aware of any training implications. An operational assessment should be conducted prior to purchase to determine if the new equipment will need to be added to the physician credentialing process or if there is a need for education for physicians, nurse and/or support staff.

Everyone in the hospital can help reduce the number of undesirable patient incidents. Don’t overlook the contribution of nonclinical departments, such as the Biomedical engineering department. Although the Biomedical engineering d staff are not involved in direct patient care, they can do a lot to minimize the risk of equipment-related adverse events.

While recognizing that errors and accidents are unavoidable, we must continuously examine and improve the design of equipment and procedures, personnel, supplies and materials, and the environment in which we work to reduce error and mitigate its effects.

We need a blame-free, litigation-free protective environment that allows and encourages anonymous reporting of near misses and serious adverse events. There must also be a partnership between patients, healthcare providers, engineers, researchers, manufacturers, and regulatory bodies to reduce and mitigate risks. Finally, healthcare providers must take a leading role in a culture of safety in their organizations.